671260
ABL Medical, LLC — FEI 3007536356
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 30, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- American Fork, UT (United States)
Citations
| ID | CFR | Description |
|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1306 | 21 CFR 110.20(b)(7) | Screening |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1560 | 21 CFR 110.35(c) | Lack of effective pest exclusion |
| 1702 | 21 CFR 110.80(b)(8) | Metal / extraneous materials |
| 2007 | 21 CFR 211.186(a) | Signature and checking of records -- 2 persons |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2302 | 21 CFR 820.20(e) | Quality System Procedures |
| 3102 | 21 CFR 820.30(h) | Design transfer - Lack of or inadequate procedures |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |